puestos de Regulatory Affairs en United States

Role: Regulatory Affairs Manager

Location: Staffordshire / Derby border

Salary - On application

• Interact with key product developers to develop Regulatory strategies for the UK. Provide advice and guidance where required to ensure dossiers are appropriate for the MHRA.
• Maintain Regulatory systems and files relating to product portfolio.
• Preparation and submission to the MHRA of post-approval activities across licence portfolio, including variation applications, change of ownership applications, renewals and PSURs.
• Liaise with Commercial colleagues/Company Directors to coordinate submissions to the MHRA, ensuring continued supply of products.
• Assist in the production of artwork, from generation of mock-ups for Regulatory submission to approval of printer proofs for manufacture.
• Undertake activities within eCTD systems for Regulatory submissions.
• Oversee Pharmacovigilance (PV) Regulatory activities, including reviewing and updating data provided by outsourced PV provider, and managing responses to Medical Information enquiries triaged back.
• Involvement in the change control process specifically for Regulatory input and organise any subsequent work/actions for Regulatory changes.
• Co-ordination with Quality Manager to ensure Regulatory information is transferred to CMOs, as required for production.
• Assist with submission, review and maintenance of entries on the electronic medicines compendium (emc).
• Stay abreast of changes in legislation and take responsibility for reviewing and assessing the implications of changes for pertaining to Regulatory Affairs.

• Ensures that all duties are carried out in compliance with the business’s applicable quality processes and SOPs, Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) and within all applicable licensing/regulatory requirements.
• Complies with health & safety, anti-bribery & corruption, data protection and other compliance programmes or requirements, in effect from time to time.
• Ensures that all duties are carried out in compliance with all contractual obligations relating to the business’s procurement and supply to customers.
• Promotes strong continuous improvement and excellence-rewarding culture.
• The above-listed tasks are not exhaustive. They provide a general indication of the tasks involved. However, the nature of the business is such that roles are likely to expand and develop over time. All of the business’s employees must be flexible in their work, in order to meet business needs.